CLASS II Device recall · Reported 24 Oct 2012 · FDA Enforcement Report

"PressFT2.6 w/ Two #1 recalled by Linvatec

Linvatec is recalling "***PressFT***2.6 w/ Two #1 (4 metric) Hi-Fi***Sutures***NP262***2009-02***Conmed, distributed nationwide in the US. The recall was initiated on 26 Jun 2012 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesItem number NP262

Quantity recalled879 units for all products in recall event

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0063-2013
FDA event ID: 63115
Recalling firm: Linvatec, Largo, FL
Classification: Class II
Status: Terminated
Recall initiated: 26 Jun 2012
FDA classified: 15 Oct 2012
Reported: 24 Oct 2012
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Hip & Knee Implants

Timeline

26 Jun 2012	Recall initiated by company
15 Oct 2012	Classified by FDA	+111 days
24 Oct 2012	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Linvatec Corporation dba ConMed Linvatec in Largo, FL is recalling PressFT HI-FI Sutures (items NP211, NP212, NP261, NP262, NP211H, NP261H-all lot numbers) due to the potential for the distal tip of the driver to become separated from the driver shaft after successful insertion of the implant.

Product as listed by the FDA

"***PressFT***2.6 w/ Two #1 (4 metric) Hi-Fi***Sutures***NP262***2009-02***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA*** To reattach soft tissue to bone in orthopedic surgical procedures

Where it was distributed

Worldwide Distribution - USA including AZ, CA, CO, FL, GA, LA, MA, ME, MI, MN, NJ, NM, NY, PA, TX, UT, and WA. Internationally to BE, CA, ES, MY, NZ and PL

Nationwide Arizona California Colorado Florida Georgia Louisiana Massachusetts Maine Michigan Minnesota New Jersey New Mexico New York Pennsylvania Texas Utah Washington

Questions about this recall

Is "***PressFT***2.6 w/ Two #1 (4 metric) Hi-Fi***Sutures***NP262***2009-02***Conmed recalled?

Yes. Linvatec recalled "***PressFT***2.6 w/ Two #1 (4 metric) Hi-Fi***Sutures***NP262***2009-02***Conmed on 26 Jun 2012. The recall is Class II and its status is Terminated. Recall number Z-0063-2013.

Why was it recalled?

Which lots are affected?

Item number NP262

Where was it sold?

Worldwide Distribution - USA including AZ, CA, CO, FL, GA, LA, MA, ME, MI, MN, NJ, NM, NY, PA, TX, UT, and WA. Internationally to BE, CA, ES, MY, NZ and PL

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Linvatec

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17 Jul 2013Device	CLASS II	*REF C7120*Apex Arthroscopy Tubing Set. Intended for use recalled	Linvatec	Other	Nationwide
17 Jul 2013Device	CLASS II	*REF C7122QTY 1**Apex Arthroscopy Tubing Set. Intended for use recalled	Linvatec	Other	Nationwide
10 Jul 2013Device	CLASS II	Genesys Cross FT Suture Anchor with Two #2 recalled by Linvatec	Linvatec	Sterility	6 states
29 May 2013Device	CLASS II	Ref: VP1600 HD Still Capture System ConMed Linvatec . Captures recalled	Linvatec	Device Malfunction	Nationwide
13 Mar 2013Device	CLASS III	D3000 Advantage Drive System, 115v recalled by Linvatec	Linvatec	Other	Nationwide

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